Impact of Aggressive Lipid-Lowering Therapy with Evolocumab on Peripheral Atherosclerotic Plaque Assessed with NIRS-IVUS in Patients with Peripheral Artery Disease

Impact of Aggressive Lipid-Lowering Therapy with Evolocumab on Peripheral Atherosclerotic Plaque Assessed with NIRS-IVUS in Patients with Peripheral Artery Disease - RESOLVE PAD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049231

Enrollment

Registered

2022-11-01

Start date

2022-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral artery disease

Interventions

In the Evolocumab group, patitents will be treated with Evolocumab 140mg every 2 week or 420 mg every 4 week until 48 weeks. Control group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with peripheral artery disease recieved endovascular therapy (2)Patients who have an LDL cholesterol level of 70 mg/dL or higher treated with maximum statin therapy (3)Presence of mild to moderate stenosis (25-75%) (4)Presence of lipid plaque with Max LCBI4mm over 100 assessed by NIRS-IVUS

Exclusion criteria

Exclusion criteria: (1) patients who are pregnant or breastfeeding (2) patients for whom evolocumab therapy is contraindicated (3) patients scheduled to undergo low-density lipoprotein (LDL) apheresis (4) patients with severe liver dysfunction (such as Child-Pugh classification C)

Design outcomes

Primary

Measure	Time frame
The amount of change in max LCBI4mm from baseline to the 12-month follow-up	—

Secondary

Measure	Time frame
1)The change in lipid-core plaque distribution from baseline to the 12-month follow-up 2)The changes in total atheroma volume and percent atheroma volume from baseline to the 12-month follow-up 3)The change in minimum lumen area from baseline to the 12-month follow-up 4) Amputation-free survival at the 12-month follow-up 5) limb salvage rate at the 12-month follow-up 6) MALE (major adverse limb events) at the 12-month follow-up 7)MACE (major adverse cardiovascular events) at the 12-month follow-up 8) Revascularization rate at the 12-month follow-up	—

Measure

Time frame

1)The change in lipid-core plaque distribution from baseline to the 12-month follow-up 2)The changes in total atheroma volume and percent atheroma volume from baseline to the 12-month follow-up 3)The change in minimum lumen area from baseline to the 12-month follow-up 4) Amputation-free survival at the 12-month follow-up 5) limb salvage rate at the 12-month follow-up 6) MALE (major adverse limb events) at the 12-month follow-up 7)MACE (major adverse cardiovascular events) at the 12-month follow-up 8) Revascularization rate at the 12-month follow-up

—

Countries

Japan

Contacts

Public ContactTomohiro Shimizu

University of Fukui Division of Cardiovascular Medicine, Faculty of Medical Sciences

s-tomo@u-fukui.ac.jp0776613111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026